Polyethylene glycol (PEG) chains are often used to modify therapeutic biologic agents in order to prolong the circulating half-life of the modified protein by slowing proteolytic degradation. It has been reported that repeatinjections of PEGylated proteins can induce anti-PEG antibodies. Anti-PEG antibodies can result in rapid clearance and decreased drug efficacy (accelerated blood clearance, or ABC, phenomenon).
Intended Use:For the qualitative determination of anti-PEG IgG antibodies in human serum and plasma.
Principle of the Assay:This immunogenicity assay uses the direct ELISA technique. The supplied stretavidin precoated 96 well microplate is incubated with biotinylated PEG (5KD). After washing, quality control and test samples are pipetted into the appropriate wells. Anti-PEG antibodies bind the immobilized PEG. After washing, detection antibody (anti-human IgG Peroxidase) is added. Any unbound antibody-enzyme reagent is removed with a final wash and a substrate solution is added to the wells for color development. Color development is proportional to the amount of anti-PEG IgG.
Storage and Stability:Store all components at -20°C. Stable for 6 months after receipt. For maximum recovery of product, centrifuge the original vial after thawing and prior to removing the cap.
